Foreign objects in foods are considered adulteration. Foreign objects can be broadly classified as 1) food safety hazards (e.g., glass) and 2) food nonsafety hazards (e.g., filth). Foreign objects that are physical hazards are referred to as hard or sharp objects. Hard or sharp objects are divided into metallic objects (Tables 28-1 and 28-2) and non-metallic objects (Table 28-3). Metallic objects are further divided into ferrous metals (Table 28-1) and non-ferrous metals (Table 28-2). Hard or sharp foreign objects in food may cause traumatic injury including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine as well as damage to the teeth and gums. From 1972 through 1997, the FDA Health Hazard Evaluation Board evaluated approximately 190 cases of hard or sharp foreign objects in food. These include cases of both injury and non-injury reported to FDA. The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly. The scientific and clinical literature supports this conclusion. Hard or sharp natural components of a food (e.g. bones in seafood, shell in nut products) are unlikely to cause injury because of awareness on the part of the consumer that the component is a natural and intrinsic component of a particular product. The exception occurs when the food's label represents that the hard or sharp component has been removed from the food, e.g., pitted olives. The presence of the naturally occurring hard or sharp object in those situations (e.g., pit fragments in pitted olives) is unexpected and may cause injury. FDA has established Defect Action Levels for many of these types of unavoidable defects in other Compliance Policy Guides and therefore they are not subject to the guidance in this document (FDA, 1999). The following tables list examples of the types of hard or sharp objects that pose a potential physical hazard and includes a section on glass fragments.
